DFB Soria, a clinical-stage pharmaceutical development company, and an affiliate of NanOlogy™, completed the second of four patient cohorts enrolled in a Phase 2 actinic keratosis (AK) clinical trial of a topical ointment containing nanoparticle paclitaxel formed by a proprietary production process.

Identified as SOR007, the ointment is being evaluated topically in a dose escalating trial for safety and preliminary efficacy. Nanoparticle paclitaxel contained in SOR007 is produced by a proprietary nanoparticle production technology that reduces the size of unprocessed paclitaxel API crystals up to 400 times into patented, stable, naked nanoparticles with exponentially increased surface area and unique geometry. NanoPac is then suspended in a topical anhydrous base, which has successfully shown penetration of the drug through the epidermis into the dermis. Along with the production process, both the nanoparticle and the ointment are patented.

“The most widely prescribed topical treatment for AK is 5-fluorouracil, which causes severe dermal irritation and significantly decreases the patient’s quality of life for several weeks,” says Gere diZerega, MD, Soria VP of Medical Affairs, in a news release. “Preclinical dermal irritation studies and a Phase 1 clinical trial of SOR007 showed minimal dermal irritation and negligible systemic absorption, and formed the basis for FDA approving the clinical protocol for our AK trial,” he says.

“Our goal is to demonstrate that SOR007 is effective without the severe topical irritation that limits other AK products,” says Maxwell Lea of Soria. “Successful results from this clinical trial will allow selection of the most efficacious SOR007 concentration to move forward into phase 3-enabling clinical trials.”